FDA Medical devices recall ·
TMJ Bilateral Implant recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0488-2026
- Date
- (initiated October 13, 2025)
- Company / brand
- TMJ Solutions Inc
6059 King Dr, Ventura, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 63 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Why was it recalled?
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 07613327626551,07613327626568,07613327626575,07613327626605,07613327627749 07613327627848/ Lot #s: 2410301062 2306091054 2312121078 2401181023 2401231058 2403191046 2404291064 2405021079 2407221023 2407241032 2408081047 2408131037 2408161043 2409031033 2409241016 2410011097 2410071065 2410091014 2410111030 2410291062 2411111012 2411121044 2411201015 2412061031 2412121062 2412201009 2501021011
Distribution
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
States: California Florida Georgia Illinois Massachusetts Maryland Minnesota Mississippi New York Oklahoma Oregon Pennsylvania Texas Utah Virginia
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0488-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.